Cognitive Dysfunction, Cognitive DisorderPhase 1MW151-102NCT05417282
MW151 and Whole-brain Radiotherapy in Patients With Intracranial Metastases
A Phase 1 study testing MW151 in people with Cognitive Dysfunction, Cognitive Disorder, run by ImmunoChem Therapeutics, LLC at 1 site in United States.
Trial summary
HYPOTHESIS: MW151 intervention during whole-brain radiotherapy for intracranial metastases is safe and well tolerated and will mitigate neurocognitive decline. RATIONALE: There is non-clinical evidence that MW151 reduces brain inflammation and improves neurocognitive outcomes in animal models of radiation therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Dysfunction, Cognitive Disorder
- What is being tested?
- MW151
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Jul 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in the study only if all of the following criteria are met:
- All patients must be willing to and have the capacity to give written informed consent and have signed and dated the informed consent form (ICF) in accordance with ICH and GCP guidelines, as an assurance that all participants understand the risks and benefits of the study
- All patients must be able to speak and understand English proficiently
- Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years
- If the original histologic proof of malignancy is > 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
- Intracranial metastases (either parenchymal brain metastases or leptomeningeal disease (LMD, also known as neoplastic meningitis, leptomeningeal carcinomatosis, or carcinomatous meningitis)) must be visible on contrast-enhanced MRI
Who cannot join
- A subject will not be eligible for inclusion in the study if any of the following criteria are met:
- Subject is lactating or is pregnant
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Show all 21Show fewer
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)
- Clinically significant abnormalities in screening laboratory tests that would affect patient safety as determined by the principal investigator
- History of psychiatric disorder requiring ongoing medical management
- History of substance abuse including alcohol within past 5 years Appropriately prescribed medication for the treatment of pain or other symptoms related to the underlying malignancy is acceptable
- Chronic kidney disease defined as the presence of significant proteinuria on urinalysis and/or eGFR of <60mL/min, as calculated by the clinical site laboratory
- Inability to follow the instructions or an unwillingness to cooperate with study procedures
- Known allergy to any component of MW151 as described in investigator's brochure
- Received treatment with and/or planned treatment with systemic chemotherapy within 3 days prior, during, or for at least 3 days after completion of whole-brain radiotherapy. Concurrent immunotherapy is permitted
- Prior whole-brain radiotherapy
- Use of chronic short-acting benzodiazepine
- Use of chronic NSAID or steroid therapies for chronic inflammatory diseases within 3 days prior to dosing and during the course of the study drug dosing. Use of aspirin for cardiac prophylaxis is acceptable. Use of any other NSAID's or steroids should be reviewed by sponsor, approved and approval documented.
- Any reason or opinion of the investigator that would prevent the subject from participation in the study
- Currently receiving treatment with and/or planned treatment with Memantine HCl or combination drugs containing Memantine HCl.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial HealthCare, Central DuPage Hospital, Warrenville Cancer Center
Winfield, Illinois, 60555
About this study
Official title: Safety and Tolerability of MW151 Administered With Whole-brain Radiotherapy in Patients With Intracranial Metastases
HYPOTHESIS: MW151 intervention during whole-brain radiotherapy for intracranial metastases is safe and well tolerated and will mitigate neurocognitive decline.
RATIONALE: There is non-clinical evidence that MW151 reduces brain inflammation and improves neurocognitive outcomes in animal models of radiation therapy induced cognitive dysfunction, and in animal models of other CNS disorders.
PURPOSE: This feasibility trial evaluated whether MW151 was safe and well tolerated and whether it mitigated neurocognitive decline following whole-brain radiotherapy in adult patients with intracranial metastases from solid tumors.
Read the detailed description
In Part A, 10 subjects will receive MW151 in an open label evaluation. At least 5 of these subjects will be male. For each subject, safety and tolerability data for the first 24 hours will be reviewed prior to the continuation of dosing. Subjects will be evaluated for safety during week 1, during week 2, and at week 4. Once the data from Part A have been reviewed by the Safety Monitoring Committee (SMC) for males and females, an additional 30 subjects will be recruited to Part B. These subjects will also receive open-label MW-151.
In both Parts A and B subjects will take study drug (males), or the first daily dose of study drug (females) before WBRT which will be administered once a day (3Gy), five days a week (Monday to Friday) for two weeks, for total of ten treatments and 30 Gy.
- Being tested
- MW151
- Keywords
- MW151, MW01-2-151SRM, whole brain radiation therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MW151Drug
Also called MW01-2-151SRM
Females: 20 mg MW151 daily (10 mg capsule BID), for 28 days; Males: 10 mg MW151 daily (10 mg capsule QD), for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Safety and tolerability evaluation | Experimental | Part A, Open-label sentinel cohort: 10 subjects will receive MW151 in an open-label safety and tolerability evaluation.
Part B, open-label main cohort. 30 subjects will receive MW151 in an open-label safety and tolerability evaluation. Receives: Drug: MW151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.
Measured: 28 days
Secondary outcomes (3)
Reduction in Cognitive Deterioration
To determine if the addition of MW151 to WBRT standard of care treatment will show a trend towards reduction in cognitive deterioration in patients with brain metastases from solid tumors, as measured by standardized NCF tests.
Measured: 6 months
Progression-free Survival and Overall Survival
To evaluate intracranial progression-free survival and overall survival following the addition of MW151 to WBRT standard of care treatment for patients with brain metastases.
Measured: 6 months
Anti-inflammatory Effects
To determine if the addition of MW151 to WBRT will have an impact on plasma levels of proinflammatory cytokines (PIC).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jul 2022
- Primary completion11 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive Dysfunction, Cognitive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoChem Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Northwestern Medicine
- Responsible party
- Sponsor
- Investigators
- Vinai Gondi, MD, Principal investigator, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417282
- Sponsor's protocol ID
- MW151-102
- Other IDs
- R44CA236382
- Acronym
- MW151-102
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2022
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of MW151 Administered With Whole-brain Radiotherapy in Patients With Intracranial Metastases
- ClinicalTrials.gov ID
- NCT05417282
- Acronym / sponsor ID
- MW151-102 / MW151-102
- Keywords
- MW151, MW01-2-151SRM, whole brain radiation therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ImmunoChem Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Northwestern Medicine
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HYPOTHESIS: MW151 intervention during whole-brain radiotherapy for intracranial metastases is safe and well tolerated and will mitigate neurocognitive decline.
RATIONALE: There is non-clinical evidence that MW151 reduces brain inflammation and improves neurocognitive outcomes in animal models of radiation therapy induced cognitive dysfunction, and in animal models of other CNS disorders.
PURPOSE: This feasibility trial evaluated whether MW151 was safe and well tolerated and whether it mitigated neurocognitive decline following whole-brain radiotherapy in adult patients with intracranial metastases from solid tumors.
Detailed description
In Part A, 10 subjects will receive MW151 in an open label evaluation. At least 5 of these subjects will be male. For each subject, safety and tolerability data for the first 24 hours will be reviewed prior to the continuation of dosing. Subjects will be evaluated for safety during week 1, during week 2, and at week 4. Once the data from Part A have been reviewed by the Safety Monitoring Committee (SMC) for males and females, an additional 30 subjects will be recruited to Part B. These subjects will also receive open-label MW-151.
In both Parts A and B subjects will take study drug (males), or the first daily dose of study drug (females) before WBRT which will be administered once a day (3Gy), five days a week (Monday to Friday) for two weeks, for total of ten treatments and 30 Gy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and tolerability evaluation | Experimental | Drug: MW151Part A, Open-label sentinel cohort: 10 subjects will receive MW151 in an open-label safety and tolerability evaluation. Part B, open-label main cohort. 30 subjects will receive MW151 in an open-label safety and tolerability evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A subject will be eligible for inclusion in the study only if all of the following criteria are met:
- All patients must be willing to and have the capacity to give written informed consent and have signed and dated the informed consent form (ICF) in accordance with ICH and GCP guidelines, as an assurance that all participants understand the risks and benefits of the study
- All patients must be able to speak and understand English proficiently
- Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years
- Intracranial metastases (either parenchymal brain metastases or leptomeningeal disease (LMD, also known as neoplastic meningitis, leptomeningeal carcinomatosis, or carcinomatous meningitis)) must be visible on contrast-enhanced MRI
Key exclusion criteria (21 listed)
- A subject will not be eligible for inclusion in the study if any of the following criteria are met:
- Subject is lactating or is pregnant
- Severe, active co-morbidity, defined as follows:
- Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)
- Clinically significant abnormalities in screening laboratory tests that would affect patient safety as determined by the principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MW151Also: MW01-2-151SRMFemales: 20 mg MW151 daily (10 mg capsule BID), for 28 days; Males: 10 mg MW151 daily (10 mg capsule QD), for 28 days. | Drug | Safety and tolerability evaluation |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 days
To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.
3 secondary outcomes
Reduction in Cognitive Deterioration
Time frame: 6 months
Progression-free Survival and Overall Survival
Time frame: 6 months
Anti-inflammatory Effects
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinai Gondi, MD principal investigator
Northwestern Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MW151 in people with Cognitive Dysfunction, Cognitive Disorder, run by ImmunoChem Therapeutics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.